A blinded randomized study of ephedrine 0.15 mg/kg for reducing onset time of rocuronium 0.6 mg/kg in elderly patients (≥ 80 years)
This study aims to find out if a common medication called ephedrine can speed up how quickly another medicine, rocuronium, works in elderly patients (aged 80 and over) who are having planned surgery. Rocuronium is a muscle relaxant often used during an anaesthetic to help with procedures like placing a breathing tube. We are comparing ephedrine to a saline solution (salt water, which has no medicine in it) to see if ephedrine makes the muscle relaxant work faster. This is important because a quicker start to the anaesthetic can make the whole process smoother for the patient. We're also checking how easy it is for doctors to place the breathing tube and if there are any changes in heart rhythm or blood pressure.
At a glance
What is this study about?
This study is about making sure that elderly patients (aged 80 and over) have the smoothest and safest experience when they need planned surgery. When you have an anaesthetic for surgery, doctors often use medicines to relax your muscles so they can gently put a breathing tube into your windpipe. One of these muscle-relaxing medicines is called rocuronium.
We want to see if another common medicine, ephedrine, which can raise blood pressure, might help rocuronium work faster. If rocuronium acts more quickly, it could mean a quicker and potentially more comfortable start to your anaesthetic. This study is like a 'Phase IV' study, which means the medicines involved are already approved and widely used, but we're looking more closely at a specific way to use them in a particular group of patients.
To make sure we get reliable results, some patients will receive ephedrine, and others will receive a saline solution (which looks exactly the same but contains no active medicine). Neither the patient nor the doctor will know who is getting which, which helps us to be sure that any differences we see are truly because of the medicine and not due to other factors. We will be very carefully monitoring how quickly the muscle relaxant works and also checking on your heart rate and blood pressure throughout the process.
Key takeaways
- Study focuses on elderly patients (80+ years) having planned surgery.
- Investigating if ephedrine helps a muscle relaxant (rocuronium) work faster.
- Patients will receive either ephedrine or a saline solution.
- This is a 'blinded' study, so you won't know which one you receive.
- Close monitoring of vital signs (heart rate, blood pressure) will occur.
- Aims to improve anaesthesia experience for older individuals.
Who may be eligible?
This study is for patients who are 80 years old or older and are scheduled to have a planned operation. This means your surgery isn't an emergency and has been arranged in advance.
Both men and women can take part in this study. The main focus is on elderly people who are having a general anaesthetic for their surgery.
Specific details about other health conditions or medications that might prevent you from joining the study would be discussed with your doctor to make sure it's safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 80 years old or older?
- Are you scheduled for a planned (non-emergency) operation?
- Will you be having a general anaesthetic for your surgery?
- Are you generally well enough for surgery as decided by your doctors?
What does participation involve?
If you decide to take part in this study, it will be integrated seamlessly into your existing surgery plan. There will be no extra visits to the hospital before or after your surgery beyond what is already planned. During your anaesthetic for surgery, you will receive either a small dose of ephedrine or a saline solution (which acts as a comparison) through an injection, just before you receive the muscle relaxant rocuronium. Neither you nor your anaesthetist will know which one you receive.
We will then carefully measure how quickly the muscle relaxant starts to work. We will also monitor your blood pressure and heart rhythm very closely, as is standard practice during any anaesthetic, but with extra attention for the study. There will be no additional follow-up appointments specifically for the study once your surgery is complete and you've recovered as usual.
Potential risks and benefits
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Common questions
What is rocuronium?
Rocuronium is a medicine used during general anaesthesia to relax your muscles, which helps doctors place a breathing tube and perform surgery.
What is ephedrine?
Ephedrine is a medicine that can help to increase blood pressure and heart rate. It's often used when blood pressure drops during anaesthesia.
Why don't I know if I'm getting ephedrine or saline?
This is called a 'blinded' study. Not knowing which solution you receive helps us make sure the results are fair and accurate, as it prevents any bias.
Will taking part change my surgery plan?
No, your planned surgery will go ahead as arranged. This study simply involves observing how certain medicines work during your anaesthetic.
What does 'TOF 0' mean?
TOF 0 is a medical measurement that shows your muscles are fully relaxed, meaning the muscle relaxant medicine has taken its full effect.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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